Site Activation Partner I – Temporary Contract

This is a fully remote position, open to applicants in Turkey.

📋 Description

• Initiate and manage activities for clinical trial site activation and essential document handling.

• Create high-quality Investigator Initiation Packages that facilitate site initiation approval.

• Prepare, validate, and submit regulatory documents such as IIP, IRB approval forms, and FDA 1572/Attestation Forms.

• Coordinate supporting roles and activities to ensure prompt site activation.

• Assist with central and local ethics committee packages, submissions, approvals, and communications.

• Aid investigators with local IRB workflows from preparation to approval.

• Prepare, manage, and disseminate clinical documentation and reports.

• Support and execute activities within the Shared Investigator Platform.

• Manage essential documents and updates throughout the study, including protocol amendments, revisions of FDA 1572/Attestation, and annual ethics approvals.

• Oversee IRB/Ethics and other committee activities.

• File documents to the Trial Master File and help with periodic quality reviews.

• Update and manage clinical trial systems to track site compliance and performance.

• Assist investigator sites and study teams in audit and inspection responses.

• Maintain communication with study teams and investigator sites, providing updates for country/site.

• Disseminate ethics approvals and inform stakeholders of site approvals.

• Conduct awareness sessions for site personnel as required.

• Identify and address issues related to investigator sites and support corrective and preventive actions.

• Serve as a subject matter expert or point of contact for site activation, systems, processes, and global initiatives.

• Mentor new hires.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Ensure compliance with Parexel processes, ICH-GCP, and relevant requirements.

⛳️ Requirements

• High school diploma or certificate with a comparable combination of education, training, and experience, or a Bachelor of Science/Bachelor of Arts or equivalent.

• At least 2 years of relevant experience in clinical site management.

• Preferred experience in the pharmaceutical industry or CRO concerning study site activation.

• Familiarity with clinical trial methodologies, ICH/GCP, FDA, and both global and local regulations.

• Must be fluent in Turkish and English.

• Strong verbal and written communication skills.

• Good technical abilities and an aptitude for learning and utilizing multiple systems.

• Understanding of clinical research and development processes as well as clinical trial operational elements.

• Comprehension of quality expectations and right-first-time principles.

• Basic knowledge of medical terminology and GCP requirements.

• Proficient in computer operations, Microsoft Suite, CTMS, eTMF, eISF, document exchange portals, Shared Investigator Platform, and ethics/regulatory portals.

• Ability to work both independently and as part of a team.

• Skilled in organizing tasks, managing time and priorities, and multitasking.

• Willingness to work flexible hours in a global environment when necessary.

• Ability to travel as needed, including potential international travel.

🏝️ Benefits

• Temporary contract.

• Full-time employment.